A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes
A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea
1 other identifier
interventional
1,036
17 countries
93
Brief Summary
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Sep 2009
Longer than P75 for phase_3 type-2-diabetes-mellitus
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
December 17, 2013
CompletedApril 7, 2015
March 1, 2015
2.9 years
August 17, 2009
September 5, 2013
March 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).
Baseline, 30 weeks
Secondary Outcomes (12)
Percentage of Participants Achieving HbA1C < 7.0%
Week 30
Percent of Participants Achieving HbA1c ≤ 6.5%.
Week 30
Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.
Baseline, Week 30
Change in Total Cholesterol From Baseline to Week 30
Baseline, week 30
Change in High Density Lipoprotein (HDL) From Baseline to Week 30
Baseline, week 30
- +7 more secondary outcomes
Study Arms (2)
Exenatide (BET)
EXPERIMENTALBasal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
Insulin Lispro (BBT)
ACTIVE COMPARATORBasal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
Interventions
subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day
titrated based on pre-meal glucose level; three times a day
Eligibility Criteria
You may qualify if:
- Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
- Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
- Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
- Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
- Have an HbA1C \> 7.0% and ≤ 10.0%.
- Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.
You may not qualify if:
- Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
- Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
- Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have previously completed or been withdrawn from this study after enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (95)
Research Site
Buenos Aires, Argentina
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Caba, Argentina
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Capital Federal, Argentina
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Ciudad Autonoma de Buenos Aire, Argentina
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Ciudad de Buenos Aires, Argentina
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Corrientes, Argentina
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Rosario, Argentina
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San Rafael, Argentina
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Arlon, Belgium
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Bonheiden, Belgium
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Edegem, Belgium
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Merksem, Belgium
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Tallinn, Estonia
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Tartu, Estonia
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Helsinki, Finland
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Oulu, Finland
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Vantaa, Finland
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Angers, France
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Auxerre, France
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Bar-le-Duc, France
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Douai, France
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La Roche-sur-Yon, France
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La Rochelle, France
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Le Creuzot, France
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Lille, France
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Marseille, France
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Montpellier, France
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Nanterre, France
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Pessac, France
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Rennes, France
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Strasbourg, France
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Toulouse, France
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Vénissieux, France
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Bad Lauterberg im Harz, Germany
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Dippoldiswalde, Germany
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Friedrichsthal, Germany
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Goch, Germany
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Grevenbroich, Germany
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Hamburg, Germany
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Mainz, Germany
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Saarbrücken, Germany
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Athens, Greece
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Thessaloniki, Greece
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Florence, Italy
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Napoli, Italy
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Olbia, Italy
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Perugia, Italy
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Trieste, Italy
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Verona, Italy
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Aguascalientes, Mexico
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Cuernavaca, Mexico
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Mexico City, Mexico
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Monterrey, Mexico
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Almere Stad, Netherlands
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Amsterdam, Netherlands
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Beek, Netherlands
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Groningen, Netherlands
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Heerlen, Netherlands
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Hoogeveen, Netherlands
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Sittard-Geleen, Netherlands
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The Hague, Netherlands
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Coimbra, Portugal
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Lisbon, Portugal
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Portugal, Portugal
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Hato Rey, Puerto Rico
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Bucharest, Romania
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Cluj-Napoca, Romania
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Constanța, Romania
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Craiova, Romania
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Oradea, Romania
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Ploieşti, Romania
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Arkhangelsk, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Seoul, South Korea
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Ulsan, South Korea
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Wŏnju, South Korea
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A Coruña, Spain
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Alicante, Spain
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Barcelona, Spain
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Dos Hermanas, Spain
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Santander, Spain
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Valencia, Spain
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Halmstad, Sweden
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Karlstad, Sweden
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Lund, Sweden
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Malmo, Sweden
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Solna, Sweden
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Stockholm, Sweden
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Umeå, Sweden
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Bournemouth, United Kingdom
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Ipswich, United Kingdom
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Leicester, United Kingdom
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Penarth, United Kingdom
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Wakefield, United Kingdom
Related Publications (1)
Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.
PMID: 25011946RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Chief Medical Officer, MD
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 18, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
April 7, 2015
Results First Posted
December 17, 2013
Record last verified: 2015-03